Gmp

NEW DELHI: Homeopathic drugs maker Dr Willmar Schwabe on Wednesday said it has received Good Manufacturing Practices Certificate (GMP) from World Health Organisation. The government made GMP certification mandatory for homeopathic manufacturing in October last year and Schwabe is the first such company operating out of India to receive this certification, it said. "A GMP certification in homeopathy product manufacturing is as important as it is in allopathy and ayurveda.

NEW DELHI: Drug maker Wockhardt Ltd today said the US health regulator has not found any issues with respect to data security and control measures at Chikalthana plant in a recent inspection, but suggested continuous voluntary compliance for "desired quality culture". "The recent inspection at the Aurangabad L1-Chikalthana site was a follow-up inspection by the US FDA as an outcome of completion of good manufacturing practise (GMP) remediation...

NEW DELHI: Pharmaceutical company Venus Remedies on Tuesday said that seven units at its Baddi plant in Himachal Pradesh have received the Good Manufacturing Practices (GMP) accreditation from Sudan's National Medicine and Poison Board. The accreditation pertains to units that produce medicines for cancer, antibiotics, cardiovascular and other specialty injections, the company said in a statement. "Venus is now looking forward to serve...

NEW DELHI: Domestic drug makers will no longer need a certificate of good manufacturing practice (GMP) from the World Health Organisation (WHO) to sell their medicines within India. The Drug Controller General of India (DCGI) has asked state drug controllers to let companies sell their brands in the country without the WHO s quality certificate, provided they comply with the quality norms set out in the Indian law. That is, if they produce the DCGI's...

NEW DELHI: Adding to Ranbaxy's regulatory troubles overseas, certain drugs produced at its Dewas plant have been barred from export to all member countries of the European Union for non-compliance to 'good manufacturing practice' norms. The EU sanction follows a decision taken by German authorities in this regard for Ranbaxy's Dewas plant, which has also faced inspections by authorities from Australia and Canada. Besides, the US drug watchdog FDA has already banned products...

NEW DELHI: Vaccine manufacturers of India along with some developing countries have decided to undertake an over $3.6 million project to support initiatives for making available affordable high quality vaccines. The Developing Countries Vaccine Manufacturers Network (DCVMN) International today announced intention to support the programme regarding access to affordable high quality vaccines. This is to be done by enabling a larger number of vaccine manufacturers to...

NEW DELHI: The government has deferred compulsory implementation of the new good manufacturing practices (GMP) norms for the drug industry by one year. As per a Union health ministry notification issued here today, drug units licensed prior to December 11, 2001, would have to comply with the new GMP norms only from January 1, 2005, instead of January 1, 2004, as notified earlier. Units licensed after December 11, 2001, have been given the licences as per the new GMP compliance, said a...

NEW DELHI: In a move that would prove to be a major reprieve to a large number of pharma companies, the Central government is planning to extend by two years the January 1, 2004 deadline for them to comply with the new good manufacturing practices (GMP) norms notified earlier this year. More than 50% of the domestic pharma units, including those in the SSI sector, would have had to shut shop, if the government had stuck to the announced schedule. Official sources said the...

NEW DELHI: Drug maker Wockhardt Ltd today said the US health regulator has not found any issues with respect to data security and control measures at Chikalthana plant in a recent inspection, but suggested continuous voluntary compliance for "desired quality culture". "The recent inspection at the Aurangabad L1-Chikalthana site was a follow-up inspection by the US FDA as an outcome of completion of good manufacturing practise...

NEW DELHI: European health regulator today lifted suspension imposed on export of drugs produced at Ranbaxy's Toansa plant to the EU stating medicines produced at the site posed no risk to public health despite having a number of manufacturing deficiencies. In a statement, the European Medicines Agency (EMA) said European regulatory authorities have finalised their assessment of reported non-compliance with Good Manufacturing Practice (GMP) at the Toansa plant. ...

NEW DELHI: Ranbaxy facilities in India are being reviewed after its US arm admitted to manufacturing certain drugs not in conformity with good manufacturing practices and which are considered "adulterated" under US law, Health Minister Gulam Nabi Azad said today. However, in India manufacturing of drugs not in conformity with GMP is viewed as non-compliance to GMP under the said Act & Rules, he said. The Minister was replying to a query in Rajya Sabha on steps taken by the...

MUMBAI: Shares of Claris Lifesciences spiked as the company got MHRA approval for its newly commissioned plant. The stock rallied over 4% in intraday trade. "This will help in enhancing capacities to grow in the regulated markets , especially the European Union," the company said in a press release. This is the first regulatory inspection and compliance approval conducted by MHRA-UK in line with the EU GMP regulations for the new plant. This approval is for...

NEW DELHI: India's drug regulator is set to restore the export certificate for Ranbaxy Laboratories' biggest ingredient facility at Toansa in Punjab. This will allow the embattled manufacturer to resume exporting medicines to European markets , which use raw materials made at the plant, officials at Drug Controller General of India's office told ET. The decision comes after global regulators from various European countries including Germany, UK and Ireland...

NEW DELHI: European health regulator today lifted suspension imposed on export of drugs produced at Ranbaxy's Toansa plant to the EU stating medicines produced at the site posed no risk to public health despite having a number of manufacturing deficiencies. In a statement, the European Medicines Agency (EMA) said European regulatory authorities have finalised their assessment of reported non-compliance with Good Manufacturing Practice (GMP) at the...

HYDERABAD: Days after the US Food and Drug Administration banned import of Ranbaxy products to America from its Toansa plant, health regulators of EU and the UK have said they are evaluating the FDA inspection findings to assess if deviations from GMP have any implication in their markets . European Medicines Agency (EMA), a body under the European Union , said Ranbaxy Laboratories site in Toansa, Punjab is a supplier of active ingredients for four...

MUMBAI: Mumbai-based Wockhardt Ltd said Britain's drug regulator has revoked the quality compliance certificate, or production licence, issued to its manufacturing plant in Gujarat. "The company has received a communication from the Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom, whereby the agency has decided to withdraw the previously issued GMP ( good manufacturing practice ) certificate to the company's manufacturing facility at Nani Daman,"...

NEW DELHI: Adding to Ranbaxy's regulatory troubles overseas, certain drugs produced at its Dewas plant have been barred from export to all member countries of the European Union for non-compliance to 'good manufacturing practice' norms. The EU sanction follows a decision taken by German authorities in this regard for Ranbaxy's Dewas plant, which has also faced inspections by authorities from Australia and Canada. Besides, the US drug watchdog FDA has already banned products...

NEW DELHI: In what could hit the country's vaccine exports estimated to be at Rs 1,500 crore, besides maligning the reputation of Indian companies, the World Health Organization (WHO) is considering dropping India from its list of recommended countries to source vaccines. WHO has found "problems with India's drug regulator and some Indian pharma companies during a recent inspection" over the implementation of the prescribed standards of the good manufacturing practices (GMP)

NEW DELHI: The government today said it has ordered the Drug Controller General of India (DCGI) to check the quality of drugs produced by Ranbaxy Laboratories and to check if the firm is following standard manufacturing norms at its various manufacturing plants. "The DCGI has already been ordered to review the good manufacturing practices compliance of the manufacturing facilities of Ranbaxy in India as well as to ascertain the quality, safety and efficacy of...

NEW DELHI: Ranbaxy facilities in India are being reviewed after its US arm admitted to manufacturing certain drugs not in conformity with good manufacturing practices and which are considered "adulterated" under US law, Health Minister Gulam Nabi Azad said today. However, in India manufacturing of drugs not in conformity with GMP is viewed as non-compliance to GMP under the said Act & Rules, he said. The Minister was replying to a query in Rajya Sabha on steps taken by the...